Oral Lichen Planus
Conditions
Keywords
Oral lichen planus, Tacrolimus ointment, Triamcinolone paste
Brief summary
The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).
Interventions
DRUG0.1 % tacrolimus ointment
applied topically to oral mucosa
DRUG0.1 % triamcinolone paste
applied topically to oral mucosa
DRUGOrabase paste
applied topically to oral mucosa
Sponsors
Kuopio University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features * Clinical score for OLP ≥ 20 at baseline * Symptomatic OLP at baseline * Washout period of 2 weeks * Age over 18
Exclusion criteria
* Pregnant or lactating women * Allergy to tacrolimus or other macrolides * Allergy to other drugs or substances used in the study * Abnormal liver function * Netherton's syndrome * Cyclosporin medication * Other regular medication that could have significant interactions with tacrolimus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical score for OLP | 1,2,3,4,5,6,7,8 and 9 weeks, 6 months | The clinical score for OLP is a measure designed by the investigators for assessing the clinical extent and type of OLP, and the symptoms experienced by the patient. The value of the score is between 0-120. |
Countries
Finland
Outcome results
None listed